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FDA to consider wider use of Tarceva

The U.S. Food and Drug Administration has raised questions about a proposed use for a drug to treat lung cancer by Melville-based OSI Pharmaceuticals Inc.

The drug, Tarceva, is now used when a prior treatment with chemotherapy has been shown to fail. OSI and its partners are seeking approval to use Tarceva as maintenance therapy in earlier stages of treatment.

OSI had submitted results of a study to the federal regulators showing that Tarceva improved overall survival when given immediately after chemotherapy.

OSI said Tarceva had "proven efficacy." Advanced lung cancer patients who received Tarceva as maintenance therapy "had a statistically significant prolonged time to disease progression and a decreased risk of death when compared with patients who received placebo," the company said in a document prepared for a committee that reviews and makes recommendations on cancer drugs to the Commissioner of Food and Drugs.

The committee is scheduled to review the application at a public meeting Wednesday. A spokeswoman for OSI declined to comment Monday before the meeting.

The committee will be asked to compare Tarceva as a maintenance therapy to Tarceva or the chemotherapy drug Taxotere - as a secondary therapy.

When used after chemotherapy fails, both Tarceva and another drug improve survival by about three months.

When used as maintenance therapy, as in the study, it was found to improve survival for about one month compared to a placebo. "This raises the question whether treatment" with either drug "after progression are better options than treatment with" Tarceva as maintenance, the filing said.

OSI is moving to Ardsley, in Westchester County.

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